Trials / Unknown
UnknownNCT05283239
Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Fujian Maternity and Child Health Hospital · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.
Detailed description
This study aims to: 1) determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection. 2) determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection. 3) determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection, and its prognostic value in women with LSIL and HSIL.
Conditions
- HPV Infection
- LSIL, Low-Grade Squamous Intraepithelial Lesions
- HSIL, High-Grade Squamous Intraepithelial Lesions
- Virus Integration
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Follow up | Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary. |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2024-11-30
- Completion
- 2024-12-31
- First posted
- 2022-03-16
- Last updated
- 2023-11-18
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05283239. Inclusion in this directory is not an endorsement.